EU MDR Technical Documentation
Technical documentation requirements under MDR (EU) 2017/745 are defined in Annex II (Technical Documentation) and Annex III (Post-Market Surveillance Documentation). This guide follows the structure of the Team-NB Best Practice Guidance (BPG) Rev.4 (2026-04-21), the most widely accepted industry standard for TD submission to notified bodies.
Document Structure (Annex II + Annex III)
Annex II -- Technical Documentation
| Section | Document | Code | Phase | Page |
|---|---|---|---|---|
| 1 | Device Description & Specification | AII-S1 | 1 | Details |
| 2 | Information Supplied by Manufacturer | AII-S2 | 1 | Details |
| 3 | Design & Manufacturing Information | AII-S3 | 1 | Details |
| 4 | GSPR Checklist | AII-S4 | 1+4 | Details |
| 5 | Risk Management (RMP & RMR) | AII-S5 | 1+4 | Details |
| 6 | Product Verification & Validation | AII-S6-VV | 2 | Details |
| 6.3.1-2 | Clinical Evaluation Plan (CEP) | AII-S6-CEP | 2 | Details |
| 6.3.3 | CER & Data Collection Report | AII-S6-CER | 3 | Details |
| 6.3.4 | PMCF Plan & Report | AII-S6-PMCF | 3+5 | Details |
| 6.3.5 | SSCP | AII-S6-SSCP | 3 | Details |
Annex III -- Post-Market Surveillance Documentation
| Section | Document | Code | Phase | Page |
|---|---|---|---|---|
| 7.1 | PMS Plan | AIII-PMS | 3 | Details |
| 7.2 | PSUR | AIII-PSUR | 5 | Details |
Administrative
| Document | Code | Phase | Page |
|---|---|---|---|
| TD Cover Letter | AII-COVER | Final | Details |
Phased Delivery Workflow
CRO projects typically follow a phased delivery approach aligned with TD section dependencies:
| Phase | Name | Key Documents |
|---|---|---|
| Phase 0 | Project Setup & Gap Analysis | Kick-off, DD review, preliminary gap analysis, RMP framework |
| Phase 1 | Device Characterisation | AII-S1, AII-S2, AII-S3, RMP, GSPR Gap Analysis |
| Phase 2 | V&V & Clinical Planning | AII-S6-VV review, CEP development, literature search execution |
| Phase 3 | Clinical Evaluation & PMS | DCR, CER, PMCF Plan, PMS Plan, SSCP |
| Phase 4 | Integration & Finalisation | RMR finalisation, GSPR final version (with all evidence references), TD Cover Letter |
| Phase 5 | Post-Certification Lifecycle | PSUR, PMCF Report, CER updates, annual surveillance support |
Note: Phase dependencies are recommended sequencing, not mandatory constraints. Some documents can be worked on in parallel depending on data availability.
Key Regulatory References
- MDR (EU) 2017/745, Annex II & Annex III
- Team-NB BPG for TD Submission, Rev.4 (2026-04-21) -- Team-NB
- IMDRF/RPS WG/N9 FINAL:2024: nIVD Regulatory Submission ToC
- MDCG Guidance Documents -- comprehensive collection of MDCG guidance referenced in TD sections
Relevant MDCG Guidance (by TD Section)
| TD Section | Key MDCG Documents |
|---|---|
| Classification | MDCG 2021-24, MDCG 2019-11 |
| Equivalence | MDCG 2020-5 |
| Clinical Evaluation | MDCG 2020-6, MDCG 2023-7, MDCG 2024-10 |
| SSCP | MDCG 2019-9 |
| PMCF | MDCG 2020-7, MDCG 2020-8 |
| PSUR | MDCG 2022-21 |
| Cybersecurity | MDCG 2019-16 |
| Harmonised Standards | MDCG 2021-5, MDCG 2020-3 |
| Borderline Products | MDCG 2022-5 |
| Orphan Devices | MDCG 2024-10 |
| Breakthrough Devices | MDCG 2025-09 |